Medical Device Software Development Plan
The Medical Device Software Development Plan provides detailed instruction on the creation of a software development plan that is harmonized with the requirements of IEC 62304:2006+A1:2015 and FDA guidance.
IEC 62304:2006+A1:2015 aligned
ISO 13485:2016 aligned
FDA QMSR aligned
MS Word Format
Instructive Document
Instant Download - Digital Content
The Medical Device Software Development Plan provides detailed instruction on the creation of a software development plan that is harmonized with the requirements of IEC 62304:2006+A1:2015 and FDA guidance.
Medical Device Software Development Plan-Overview
The Software Development Plan addresses content contained within IEC 62304:2006+A1:2015, ISO/IEC/IEEE 12207:2026 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed.
Medical Device Software Development Plan-Compliance
The Medical Device Software Development Plan is IEC 62304:2006+A1:2015, ISO 13485:2016 and FDA QMSR aligned.
Regulatory framework
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
